GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US clinical stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma. 1 August 2024
Eisai and Biogen have announced that Israel has approved their Alzheimer's treatment, Leqembi (lecanemab), adding to nods in the USA, Japan, China, South Korea, and Hong Kong. 12 July 2024
Contract research and development organization (CDMO) Emergent BioSolutions has announced that Johnson & Johnson will pay $50 million to resolve claims linked to a terminated manufacturing deal for the latter’s COVID-19 vaccine. 11 July 2024
Japan’s Eisai and US biotech Biogen have announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment of Alzheimer’s disease (AD). 11 July 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers, the drug’s developers announced on Monday. 29 December 2020
China's National Health Security Administration (NHSA) has announced the annual results from the National Reimbursement Drug List (NRDL) negotiations in 2020, according to a client noted from SVB Leerink Research analyst Andrew Berens. 28 December 2020
UK government officials confirmed on Sunday that the Medicines and Healthcare products Regulatory Agency (MHRA) would imminently approve the Oxford COVID-19 vaccine, adding that the announcement could come as soon as Tuesday, according to the Financial Times. 28 December 2020
British scientists are trialling a new drug that could prevent people who have been exposed to the novel coronavirus from going on to develop COVID-19, which experts say could save many lives, the UK Guardian newspaper reported today (December 26). 26 December 2020
US pharma major Bristol Myers Squibb yesterday announced a disappointing update on its CheckMate -548, a Phase III trial evaluating the addition of Opdivo (nivolumab) to the current standard of care (temozolomide and radiation therapy) versus placebo plus the standard of care in patients with newly diagnosed glioblastoma multiforme (GBM) with O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation following surgical resection of the tumor. 24 December 2020
A2 Biotherapeutics has entered into an agreement with pharma giant Merck & Co, whereby A2 will continue research and pre-clinical development of its undisclosed Tmod cell therapy candidate. 24 December 2020
US biotech Moderna says that medicines regulator Health Canada has authorized its vaccine against COVID-19, mRNA-1273, for the immunization of people 18 years of age and older under an Interim Order. 24 December 2020
US pharma giant Merck & Co has entered into an agreement with the US Department of the Health and Human Services (HHS) and the Department of Defense (DoD) to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) on approval or Emergency Use Authorization (EUA) from the US Food and Drug Administration. 23 December 2020
US pharma giant Pfizer and German partner BioNTech have signed a second deal with the US government to supply an additional 100 million doses of BNT162b2, their COVID-19 vaccine, from production facilities in the USA. 23 December 2020
Privately-held US biotech Skyhawk Therapeutics and Vertex Pharmaceuticals have signed a strategic research collaboration and licensing agreement aimed at the discovery and development of novel small molecules that modulate RNA splicing for the treatment of serious diseases. 23 December 2020
The European Commission has approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection for the treatment of early and metastatic HER2-positive breast cancer. 23 December 2020
company Regenxbio has entered into an agreement to sell a portion of the royalty rights due to the company from Novartis Gene Therapies (formerly AveXis) from the net sales of Zolgensma (onasemnogene abeparvovec-xioi) to entities managed by Healthcare Royalty Management (HCR) for a gross purchase price of $200 million. 23 December 2020
US biotech Rhythm Pharmaceuticals today reported top-line results from its pivotal Phase III clinical trial evaluating setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, for the treatment of insatiable hunger and severe obesity in individuals with Bardet-Biedl syndrome (BBS) or Alström syndrome, two ultra-rare genetic diseases that often manifest with these symptoms. 22 December 2020
Sosei Group and Captor Therapeutics are kicking off a collaboration to discover and develop drugs focused on G protein-coupled receptors (GPCRs). 22 December 2020
Shares of the Cambridge, Mass, U SA-based Agios Pharmaceuticals closed up more than 28% at $42.62 yesterday, in reaction to the news that it is selling its oncology business, aiming to focus on genetically-defined diseases. 22 December 2020
Netherlands-based gene therapy company uniQure saw its shares down 15.7% at $38.75 around midday in New York trading today, after it announced that its hemophilia B gene therapy program, including the pivotal, Phase III HOPE-B study, has been placed on clinical hold by the US Food and Drug Administration. 21 December 2020
UK drugmaker GlaxoSmithKline has inked two early pipeline deals in neurology and immunology, boosting its investment in genetically validated treatments. 21 December 2020